Introduction

We have spent this year developing ourselves as entrepreneurs as well as biologists and engineers. What follows is

a description of our progress toward minimum viable product,
and the current draft of our business plan.

This plan builds on our scientific (description, results) and human practices research documented on other wiki pages, as well as our market research documented here.

Minimum Viable Product (MVP)

Progress Summary

Wearable Sensor: Subcutaneous aptamer probe.
- Aptamer detection: research and early prototyping
- Electronic components: first iteration designed
- Mechanical components: first iteration prototyped
- Next steps:
  - integrate technologies and optimize aptamer detection
Transmitter: Adhesive skin patch sending data to phone.
- Bluetooth transmission prototype completed.
- Next steps:
  - prepare to integrate with wearable sensor technologies
Mobile App: Real-time monitoring, alerts, history tracking.
- Prototype wireframe completed.
- Next steps:
  - functional front end
  - integrate with transmitter prototype, web services
Website: Live domain established to build awareness.
- Landing page complete
- Next steps:
  - establish web services with user accounts

Wearable Sensor

Provisional patent for device

Submitted 6 Oct 2025. Patent No: 72589908

Ongoing aptamer experiments in lab

(see Experiments, Results, and Description pages)

Biosensor applicator prototyped:

Biosensor electronics schematic identified and drafted (based on Meloni, G. N.¹)

Transmitter

Basic hardware to bluetooth app connection prototyped

Mobile App

App wireframe prototyped

Website

Landing page with branding

INARA Health Business Plan

Executive Summary

INARA Health is dedicated to empowering women through the world’s first wearable continuous progesterone monitor. Miscarriages affect 1 in 5 pregnancies in the US, with many occurring before a woman even sees her OB-GYN. Miscarriage leaves thousands of couples devastated each year (see home page and description page).

Our product is a biosensor-based wearable device that continuously tracks progesterone levels, transmits data to a smartphone app, and provides real-time feedback about the pregnancy. This tool would - Surpass existing progesterone monitors in technical capabilities and convenience - Help reduce uncertanty about a pregnancy’s status, providing real-time feedback - Make inferences about a pregnancy’s future status - Provide women who sometimes feel brushed aside by medical providers with a tool for self advocacy - Provide monitoring maximizing the effectiveness of in-vitro fertilization

This same technology would also have an impact in the cycle tracking (including fertility window prediction) sector, which currently commands a significant market. It would - Provide a new level of accuracy and convenience in fertility window prediction - Help women characterize irregular menstrual cycles and communicate this information clearly with providers

Across the board, this technology would - Represent a powerful new data collection tool for women’s health researchers

Market research shows an estimated $30M/year opportunity in the fertility and assisted reproduction technologies sector in the United States, with no existing competitors currently providing continuous progesterone monitoring. INARA Health aims to be the first mover and build a trusted platform for hormonal health.

Customer Discovery & Needs Validation

Survey Results: - Over 56% of women in a survey of 212 women across the U.S. said they would track their progesterone levels if given the opportunity, with 51% interested in using our specific device after given a description. Women expressed a variety of reasons for interest in a progesterone monitor, including period tracking and fertility concerns. - In another survey, focused more directly on miscarriage, we found that 81% of 81 women surveyed would want to know about a miscarriage as soon as possible before their next appointment.

Unmet Needs:

One interviewee spent four years seeking answers about her irregular periods:
- “If I’d had something like this, maybe doctors would’ve believed what I was telling them, and the process would’ve been so much faster.”
Some women report anticipation and anxiety about pregnancy
- anxiety about whether their pregnancy “would take”
- a desire to know if “there were any issues [in subsequent pregnancies]”
Others feel a lack of trust or sympathy from clinicians
- “Something that I wish I knew at the beginning of her pregnancy journey is that, It’s okay to fight for myself”
- “My doctor [labeled my situation as] common, [they] were not as sympathetic”

Expert Interest:

We interviewed a pregnancy researcher (Dr. Arroyo) and OB-GYNs (Dr. Zarek, Dr. Ollerton), and found that there is more interest in a continuous progesterone monitor among prospective users and the pregnancy researcher we interviewed than among the OB-GYNs.

The clinicians’ lack of interest stemmed mainly from the perspective that - miscarriage is unavoidable and a normal part of life, and that - all necessary preventative efforts (hormonal supplementation) are already in place.

Although these beliefs are not necessarily false, they imply an attitude of complacency, which may be related to the feelings of dissatisfaction in the women we interviewed.

In contrast, the pregnancy researcher we interviewed, Dr. Arroyo, was very interested in the device. He affirmed its potential to impact research in reproductive health, and its potential to enhance diagnoses and intervention clinically.

Additional expert opinions to explore include IVF and other ART clinics.

Feasibility

Biological Feasibility: Progesterone is a key hormone linked to pregnancy maintenance. Studies show that drops below a personal baseline correlate with miscarriage risk (see home page, description page).

Technical Feasability:

Components: - Sensor: Aptamer-based biosensor under the skin detects progesterone.Electrochemical aptamer detection currently in prototyping and troubleshooting phase. - Electronics: Wireless transmitter developed (schematics complete). - App: Wireframe designed with features for alerts and data visualization. - Injector: Prototype in development.

Technical risks we have addressed: - sufficient specificity of the aptamer detector (see circular dichroism results) - aptamer does not appear to be sensitive to DHT or to cholesterol, which have related chemical structures - sufficient sensitivity of the aptamer detector (see our validation of Kd values in results and measurement) - Kd values measured by us are somewhat higher than that reported in the literature

Greatest remaining technical risks: - sufficient sensitivity of the aptamer detector - sufficient durability of the aptamer detector - problems in complex solution (e.g., interstitial fluid)

Possible Mitigation strategies: - sensitivity issues - aptamer optimization (e.x., targeted truncations) - development of new aptamer sequence - durability issues - in-depth profiling - aptamer modifications (e.x., modified nucleotides) - in all cases - engage with additional experts for specific guidance - if needed, pivot to other continuous monitoring strategies - enzymatic detection (used in glucose monitors) - molecular shape-preserving gold electrodes

Safety & Regulatory:

Our regulatory pathway follows a staged approach to balance early market entry with long-term credibility:

Phase 1 – IDE Certification: Apply for an Investigational Device Exemption (IDE) to run controlled clinical tests and validate safety/accuracy.

Phase 2 – LDT Certification: Partner with a CLIA-certified lab to launch as a Laboratory Developed Test (LDT), allowing early consumer access while collecting real-world data and building trust.

Phase 3 – FDA 510(k) Clearance: Pursue FDA 510(k) approval to achieve broad healthcare adoption, insurance reimbursement, and integration into the clinical toolkit.

This phased strategy accelerates commercialization through the LDT pathway while building the clinical and regulatory evidence required for full FDA clearance.

Market Analysis

Market Size:
- Total Addressable Market (TAM): $6 billion - The entire U.S. fertility/ART market (Statifacts, 2024)
- Serviceable Addressable Market (SAM): $300 million - Assuming early pregnancy monitoring and period/ovulation tracking services would represent 5% of the U.S. fertility market
- Serviceable Obtainable Market (SOM): $30 million - Assuming we could capture 10% of this market

Statifacts. (2024). Fertility market size 2024 to 2034 (USD Billion) [Chart]. Statifacts Market Insights.

Competition:
- Existing wearables (Ava, Mira) focus on ovulation, not miscarriage prevention.
- No direct competitors in continuous progesterone monitoring, competitors in the similar realm of
  - urine-based measurements of progesterone (less frequent and convenient) - Mira
  - indirect physiological measurements (less direct) - Ava.
Customer Segments:
- Primary: Women in early pregnancy (weeks 1–12), aged 25-40, living in the United States who have experienced previous pregnancy loss or are concerned about miscarriage risk. This includes women who want deeper insights into their hormonal health, those undergoing fertility treatments, and those with histories of recurrent pregnancy loss who are actively seeking preventative solutions.
- Secondary: Women who are monitoring cycles, or are going through fertility or IVF treatment, who wish to have a more convenient monitoring option.
Market Position Analysis
- As the pioneer in continuous progesterone monitoring, INARA Health occupies a unique position in the women’s health market with significant barriers to entry for potential competitors.
- Our proprietary biosensor technology creates a defendable market position through both technical innovation and first-mover advantage in an underserved segment.
  - Our submission of our provisional patent represents the first critical step in maintaining this defendable market position.
- The intersection of wearable technology and fertility health represents a blue ocean opportunity with limited competitive pressure and strong differentiation.
Target Market Strategy
- Primary focus on miscarriage related segment: women experiencing miscarriage (~1M annually in United States)
- Secondary expansion into cycle tracking and fertility-focused sectors, like those undergoing fertility treatments (for example, ~400K IVF cycles were performed in 2022).
Adoption Drivers
- Emotional urgency and peace of mind
- Technological superiority and convenience compared to traditional monitoring
- First-mover advantage in continuous hormonal tracking
- After research and trust building: clinical validation and healthcare provider recommendations

Scalability & Commercialization Path

Production Strategy

Production Strategy: We will work with reputable laboratories to create early prototypes, leveraging their expertise and equipment for initial development. As we transition to commercialization, we plan to establish strategic manufacturing partnerships with medical device manufacturers who have experience with FDA-regulated products. This hybrid approach allows us to maintain quality control while scaling efficiently.
Production Costs Analysis: As we scale production and establish strategic supply chain partnerships, our manufacturing costs will progressively decrease. Initial prototypes have higher unit costs due to specialized laboratory requirements, while later mass production will benefit from economies of scale. We’re also continuously refining our design to reduce material costs without compromising quality or effectiveness.
Quality Control Measures: Our comprehensive QA strategy includes rigorous testing at each production stage, ISO 13485 medical device quality management systems compliance, batch testing protocols for sensor accuracy, automated electronic testing for signal reliability, and a dedicated QA team to monitor manufacturing partners. Additionally, we’ll implement statistical process control methods to ensure consistent product quality across production runs.

Partnerships & Distribution

Key Strategic Partnerships: We will pursue partnerships with leading fertility clinics and women’s health networks to establish clinical credibility and create direct referral channels. Additionally, we’ll target venture capital firms specializing in FemTech and healthcare (e.g., Portfolia FemTech Fund, Astarte Ventures) who can provide both capital and strategic connections.
Supply Chain Partnerships: We will establish relationships with specialized medical device manufacturers who can produce our biosensors, transmitters, and injectors according to FDA standards. These partnerships will be crucial for scaling production while maintaining quality control.
Research Collaborations: Partnering with academic research institutions will strengthen our clinical validation and provide opportunities for continued innovation in hormone monitoring technology.
Healthcare Integration: We’ll develop partnerships with electronic health record (EHR) providers to enable seamless data sharing between our platform and healthcare providers’ systems, creating additional value for both patients and clinicians.
Partnership Terms: To accelerate our growth and secure necessary resources, we’ll offer strategic partners different engagement models:
- Fertility Clinics: Revenue-sharing arrangements (15-20%) for patient referrals and early clinical validation opportunities.
- Research Institutions: Co-authorship on publications, access to anonymized data, and potential licensing agreements.
- Investors: Equity stakes (5-15% depending on stage) with board representation for investments exceeding $1M.
- Manufacturing Partners: Long-term exclusivity agreements with volume-based pricing tiers and quality assurance protocols.
- Medical Networks: Integration fees plus subscription revenue sharing (10-15%) for healthcare system implementations.
Distribution Strategy:
- Initial Phase: Direct-to-consumer through our own website, focusing on building brand recognition and establishing direct relationships with early adopters.
- Growth Phase: Expansion through specialized retail distributors in the fertility and women’s health space, supported by a dedicated sales team to increase market penetration.
- Mature Phase: Following FDA approval, partnerships with clinicians, fertility centers, and OB-GYN practices to integrate our product into standard care protocols and enable prescription-based distribution.

Milestones, Timeline & Risks

Milestones

0–18 months: Secure initial funding, file provisional patents, develop early prototype, and complete foundational research.
18–30 months: Conduct preliminary user testing and initial market validation with small cohorts.
30–42 months: Refine prototype based on feedback, submit IDE certification application, and begin expanded validation with larger test groups.
3.5–5 years: Obtain LDT certification, collect clinical data, and prepare FDA 510(k) submission process.
5–7 years: Navigate FDA clearance process, begin limited market entry, and develop global scaling strategy.

Risks & Mitigation

Technical risk: Aptamer sensitivity may not meet clinical thresholds needed for accurate progesterone detection → Mitigate with expanded R&D testing across varied conditions (temperature, pH), partnerships with aptamer development specialists, and leveraging advisor network expertise in biosensor optimization. See also feasibility.
Regulatory risk: FDA process could delay launch timeline by 12-18 months → Partner with clinical researchers to strengthen submissions with robust clinical data, engage regulatory consultants early in the process, and pursue parallel pathways (IDE and LDT) to ensure market entry while full approval is pending.
Adoption risk: Customer anxiety from false alarms could damage trust and reputation → Develop machine learning algorithms for personalized baseline thresholds that adapt to individual hormone patterns, implement clear clinical guidance for interpreting alerts, and create a tiered alert system (caution vs. urgent) to reduce alarm fatigue.
Manufacturing risk: Scaling production while maintaining quality could prove challenging → Establish redundant supplier relationships, implement comprehensive quality control protocols at each production stage, and develop contingency plans for manufacturing bottlenecks.
Financial risk: Extended development timelines could deplete funding before revenue generation → Create milestone-based funding strategy with clear go/no-go decision points, pursue non-dilutive funding through grants, and establish strategic partnerships to share development costs.

Team, Skills & Stakeholders

Team Composition

Eight interdisciplinary BYU students with diverse expertise across biology, engineering, and business disciplines.

Roles:
- Biology Team (2 members): Specializing in aptamer development, biochemical assay design, and hormone sensor validation.
- Engineering Team (2 members): Focused on injector mechanics, electronics design, and sensor integration.
- Product/App Team (2member): Developing user interface, data visualization, and companion application.
- Strategy/Business (2 members): Managing business plan development, market research, and investor relations.

Human Resources Strategy

Key Hiring Timeline:
- Pre-seed (0-12 months): Maintain lean founding team while engaging specialized consultants for regulatory and technical needs.
- Seed Stage (12-24 months): Hire CTO, R&D Director, and Regulatory Affairs Manager to oversee product development and compliance.
- Series A (24-36 months): Expand with Clinical Research Director, Operations Manager, and Marketing Director as we prepare for market entry.
- Growth Stage (36+ months): Add Sales Director, Customer Success Manager, and additional engineering talent to scale operations.
Required External Expertise:
- Patent Attorney: Specialized in biosensor and medical device IP ($25,000-$40,000 initially for comprehensive patent filing and protection).
- Regulatory Consultant: FDA submission expert with experience in Class II medical devices ($15,000-$20,000 monthly retainer during submission periods).
- Manufacturing Engineer: Contract expertise for production setup and quality systems ($100,000-$150,000 annually).
- Clinical Trial Coordinator: Managing validation studies and data collection ($80,000-$120,000 annually during trial phases).
- Medical Science Liaison: Building relationships with fertility clinics and OB-GYNs ($90,000-$110,000 annually plus commission structure).

Financial Overview

Facilities Planning

We plan to remain local in Utah during our initial development phase. Until formal funding is secured, our team will operate remotely and utilize shared lab and university resources. BYU facilities and local partner labs will provide access to essential equipment for prototyping, biochemical validation, and early testing.

Within five years, we plan to establish a small office and lab space in the Provo–Lehi area to centralize R&D operations, marketing, and administration. Until then, collaboration with local labs and partnerships with BYU, BioHive, and regional accelerators will help us meet validation and manufacturing needs cost-effectively.

Financial Planning

Funding Sources

Our early revenue and funding will primarily come from non-dilutive sources such as grants, competitions, and innovation prizes. We are targeting the following:

BYU SIOY (Student Innovator of the Year) Competition
Bed-to-Bedside Competition (University of Utah)
Small Business Innovation Research (SBIR) Grant
Women’s Health Research Grant
BYU BioHive Grant
Utah Innovation Fund
Kickstarter Campaign
BYU Rollins Center Miller’s Grant
Utah Innovation Hub Grant

These funds will support R&D, prototyping, and initial regulatory steps before investor capital or strategic partnerships are sought.

Cost Breakdown

Our primary expenses will be research-driven and validation-oriented during the first 18–24 months. Estimated allocation:

Category	Estimated Annual Cost (Year 1–2)	Description
Research & Development	$10,000–$15,000	3D printing, sensor materials, aptamer synthesis, modeling, and lab testing supplies
Validation & Testing	$5,000	Lab partnerships, data collection, early clinical input
Software & Services	$2,000	Website hosting, domain, subscription tools (Canva, Figma, analytics platforms)
Marketing & Outreach	$3,000	Surveys, digital ads, promotional videos for validation
Legal & Regulatory	$2,000	Early legal consultation, documentation for LDT and IDE pathways
Miscellaneous & Contingency	$1,000	Travel, equipment repairs, unforeseen costs

Total Year 1–2 Cost Estimate: $20,000–$28,000

Long-Term Impact

Positive Impacts: Reduced miscarriage-related grief, empowerment through real-time health data, potential to expand into broader hormone health markets.
Negative Impacts: Anxiety due to false positives, risk of inequitable access, data privacy concerns.
Mitigation: Build transparent communication into app, strong data security protocols, clinical validation partnerships.

References

Brown, A., Brill, J., Amini, R., Nurmi, C. & Li, Y. Development of Better Aptamers: Structured Library Approaches, Selection Methods, and Chemical Modifications. Angewandte Chemie International Edition 63, e202318665 (2024).
Fallah, A., Imani Fooladi, A. A., Havaei, S. A., Mahboobi, M. & Sedighian, H. Recent advances in aptamer discovery, modification and improving performance. Biochem Biophys Rep 40, 101852 (2024).
Alhadrami, H. A., Chinnappan, R., Eissa, S., Rahamn, A. A. & Zourob, M. High affinity truncated DNA aptamers for the development of fluorescence based progesterone biosensors. Analytical Biochemistry 525, 78–84 (2017).
What are the 2025 Fertility Statistics I Need to Know About? https://www.cofertility.com/family-learn/fertility-statistics.
Vaddiraju, S., Burgess, D. J., Tomazos, I., Jain, F. C. & Papadimitrakopoulos, F. Technologies for Continuous Glucose Monitoring: Current Problems and Future Promises. J Diabetes Sci Technol 4, 1540–1562 (2010).
Soyama, F., Motomura, T. & Takemura, K. Molecular Shape-Preserving Au Electrode for Progesterone Detection. Sensors 25, 1620 (2025).
Meloni, G. N. Building a Microcontroller Based Potentiostat: A Inexpensive and Versatile Platform for Teaching Electrochemistry and Instrumentation. J. Chem. Educ. 93, 1320–1322 (2016).